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Qualified candidates may send their resume to firstname.lastname@example.org for immediate consideration.
The Product Engineer/Designer position is responsible for:
- Developing product concepts following procedures per ISO and FDA utilizing processes. Coordinating the Product Development team to support any new/re-design products.
- Prepare/Review drawings for engineering, production and quality control as requested
- Define Manufacturing protocols
- Assist with Quality control of products before shipping and assist with quality related issues and be involved on resolution team
- Maintain drawings within the Device Master Record
- Create formal process documentation such as Work Instructions Inspection Procedures Manufacturing Procedures.
Minimum of 4 year technical degree (BS/ME preferred) or similar work experience required.
- Knowledge of manufacturing assembly ,QA, manufacturing environments including plastics, metals materials preferred.
- Knowledge of DOE, FMEA and Risk Management process preferred
- 5+ years work experience as a Product Designer utilizing Design Control Procedures with Medical Devices (ISO 13485 or ISO 9001 certified company)
- 5+ years experience on Product Development teams with Medical Device Required